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Peer-reviewedCC BY 4.0Frontiers in Pharmacology

Clinical characteristics and prognosis of liver injury in patients receiving immune checkpoint inhibitor-based therapy: a real-world retrospective study

  • Liang Gao1
  • Xiaotian Yang2
  • Fengkun Yang1
  • Guiling Shi1
  • Yuan Jiang1
  • Zhenying Zhao1
  • Meisa Wang1
  • Yuyang Gao1
  • Tao Han3
  1. 1Department of Pharmacy, Tianjin Union Medical Center, The First Affiliated Hospital of Nankai University
  2. 2School of Medicine, Nankai University
  3. 3Department of Gastroenterology and Hepatology, Tianjin Union Medical Center, The First Affiliated Hospital of Nankai University
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Abstract

Aims: This study aimed to examine the clinical characteristics, injury patterns and 6-month recovery of liver injury in patients receiving immune checkpoint inhibitor -based therapy.

Methods: We conducted a retrospective study of patients receiving ICIs at Tianjin Union Medical Center (The First Affiliated Hospital of Nankai University) between January 2020 and June 2024, with follow-up censored December 2024 and a minimum 6 months. We analysed the clinical characteristics, severity, dynamic changes in liver function, and recovery factors of patients with ICI-based therapy-related liver injury (ICI-LI).

Results: Of 682 patients, 83 (12.17%) developed ICI-LI (cholestatic 73.49%, mixed 20.48%, hepatocellular 6.02%). Among 83 patients, baseline alkaline phosphatase (ALP), gamma-glutamyl transferase, and total bilirubin, and peak alanine aminotransferase (ALT) and aspartate aminotransferase (AST) trend to be higher with greater liver injury severity. The rate of change in liver function parameters differed by subtype: hepatocellular injury showed rapid ALT/AST increases, cholestatic injury a marked but slower ALP increase, and mixed injury features of both. In univariate analysis, age, peak ALT, and neutrophil-to-lymphocyte ratio (NLR) > 3 were associated with poor 6-month recovery ( P < 0.05); in multivariate analysis, only NLR >3 remained associated (OR = 10.917, 95% CI 1.552-76.817, P = 0.016). ROC analysis yielded AUCs of 0.702 for continuous NLR (cut-off 2.955, rounded to 3) and 0.694 for NLR >3.

Conclusion: Cholestatic injury was the predominant subtype with PD-1/PD-L1 inhibitor-containing therapy. Changes in liver function parameters varied according to the clinical pattern. NLR >3 warrants further investigation as a potential exploratory biomarker for poor recovery in ICI-LI.

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Cite

BibTeXRIS
BibTeX
@article{gao2026clinical,
  title = {{Clinical characteristics and prognosis of liver injury in patients receiving immune checkpoint inhibitor-based therapy: a real-world retrospective study}},
  author = {Liang Gao and Xiaotian Yang and Fengkun Yang and Guiling Shi and Yuan Jiang and Zhenying Zhao and Meisa Wang and Yuyang Gao and Tao Han},
  journal = {Frontiers in Pharmacology},
  year = {2026},
  month = oct,
  doi = {10.3389/fphar.2026.1957181},
  url = {https://www.frontiersin.org/articles/10.3389/fphar.2026.1957181/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Clinical characteristics and prognosis of liver injury in patients receiving immune checkpoint inhibitor-based therapy: a real-world retrospective study
AU  - Liang Gao
AU  - Xiaotian Yang
AU  - Fengkun Yang
AU  - Guiling Shi
AU  - Yuan Jiang
AU  - Zhenying Zhao
AU  - Meisa Wang
AU  - Yuyang Gao
AU  - Tao Han
PY  - 2026
DA  - 2026/10/26
JO  - Frontiers in Pharmacology
DO  - 10.3389/fphar.2026.1957181
UR  - https://www.frontiersin.org/articles/10.3389/fphar.2026.1957181/full
AB  - Aims: This study aimed to examine the clinical characteristics, injury patterns and 6-month recovery of liver injury in patients receiving immune checkpoint inhibitor -based therapy.  Methods: We conducted a retrospective study of patients receiving ICIs at Tianjin Union Medical Center (The First Affiliated Hospital of Nankai University) between January 2020 and June 2024, with follow-up censored December 2024 and a minimum 6 months. We analysed the clinical characteristics, severity, dynamic changes in liver function, and recovery factors of patients with ICI-based therapy-related liver injury (ICI-LI).  Results: Of 682 patients, 83 (12.17%) developed ICI-LI (cholestatic 73.49%, mixed 20.48%, hepatocellular 6.02%). Among 83 patients, baseline alkaline phosphatase (ALP), gamma-glutamyl transferase, and total bilirubin, and peak alanine aminotransferase (ALT) and aspartate aminotransferase (AST) trend to be higher with greater liver injury severity. The rate of change in liver function parameters differed by subtype: hepatocellular injury showed rapid ALT/AST increases, cholestatic injury a marked but slower ALP increase, and mixed injury features of both. In univariate analysis, age, peak ALT, and neutrophil-to-lymphocyte ratio (NLR) > 3 were associated with poor 6-month recovery ( P < 0.05); in multivariate analysis, only NLR >3 remained associated (OR = 10.917, 95% CI 1.552-76.817, P = 0.016). ROC analysis yielded AUCs of 0.702 for continuous NLR (cut-off 2.955, rounded to 3) and 0.694 for NLR >3.  Conclusion: Cholestatic injury was the predominant subtype with PD-1/PD-L1 inhibitor-containing therapy. Changes in liver function parameters varied according to the clinical pattern. NLR >3 warrants further investigation as a potential exploratory biomarker for poor recovery in ICI-LI.
SN  - 1663-9812
ER  -